Investigator Initiated Research

An investigator initiated study is an application where the investigator is conducting the study and acting as the sponsor. The investigator both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. An investigator initiated study does not include a corporation or an agency. The obligations of the investigator include both those of a sponsor and those of an investigator.

For protocols that are Investigator Initiated the following tools should be used to assist in developing and conducting your research:

• Investigator Manual 
• Concomitant Medications  
• Continuing Review Table to Report SAE's 
• Data and Safety Monitoring Plan 
• Full Protocol Template  
• General Requirements for Informed Consent 
• HIPAA Authorization Form 
• Inclusion/Exclusion Checklist 
• New Protocol Checklist 
• Protocol Adverse Event Log  
• Sample Letter of Invitation-Phone Interview  
• Sample Letter of Invitation-Survey 
• Signature - Responsibility Log  
• Subject Adverse Event Log  
• Subject Screening-Enrollment Log  
• QI Self Assessment Tools 
• Evaluation to Sign Consent Form 
• Tools & Tips for Writing a Clear and Appropriate Informed Consent Document 
• Data Use Agreement 
• Obtaining Human Research Data Under HIPAA 
• Delegation of Responsibility Log 
• Tips for Submitting Renewals 
• Economic Interest Disclosure